U.S. patent application number 12/363499 was filed with the patent office on 2009-08-06 for system for gene testing and gene research while ensuring privacy.
Invention is credited to Richard Timothy McNamar.
Application Number | 20090198519 12/363499 |
Document ID | / |
Family ID | 40932538 |
Filed Date | 2009-08-06 |
United States Patent
Application |
20090198519 |
Kind Code |
A1 |
McNamar; Richard Timothy |
August 6, 2009 |
SYSTEM FOR GENE TESTING AND GENE RESEARCH WHILE ENSURING
PRIVACY
Abstract
A system, method and program product, the method comprising, in
one embodiment, providing a secure testing service for patient's
identification and payment data encrypted at the data level,
non-identifiable method for a patient to have a genetic tests to
identify variants or mutations of their genes or combinations of
genes that predispose the patient to develop or have an identified
disease, comprising: obtaining electronically genomic information
for a patient comprising at least one of, (a) DNA information, (b)
RNA information, (c) complementary DNA or RNA information, (d)
transfer RNA (tRNA) information (e) messenger RNA (mRNA)
information, and (f) Expressed Sequence Tags (EST) to identify an
abnormal gene; searching by one or more computers electronic
databases using the identified abnormal gene to obtain genetic
sequencing and basic research, patient predispositions, and
pharmacognetics that predict the response and reaction of patients
with identified genetic abnormalities related to the identified
abnormal gene and individual medications that may be prescribed
relating to the identified abnormal gene or a relationship with
said identified abnormal gene; performing an update search on at
least a periodic basis to learn about subsequent genomic research
developments and treatments for the identified abnormal gene,
specific genes with variants or mutated genes identified in the
genetic test; sending electronically via an Internet communication
link data comprising or derived from the searching step and the
update search to the patient or a third party; and with the sending
step performed using a privacy component that prevents transmission
to any third party unless predetermined permission clearance data
is in the system.
Inventors: |
McNamar; Richard Timothy;
(Falls Church, VA) |
Correspondence
Address: |
FOLEY AND LARDNER LLP;SUITE 500
3000 K STREET NW
WASHINGTON
DC
20007
US
|
Family ID: |
40932538 |
Appl. No.: |
12/363499 |
Filed: |
January 30, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61006785 |
Jan 31, 2008 |
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Current U.S.
Class: |
705/3 ;
707/999.005; 707/E17.014; 707/E17.032 |
Current CPC
Class: |
G16H 10/60 20180101;
G16H 10/40 20180101; G16B 50/00 20190201 |
Class at
Publication: |
705/3 ; 707/5;
707/E17.032; 707/E17.014 |
International
Class: |
G06Q 50/00 20060101
G06Q050/00; G06F 17/30 20060101 G06F017/30 |
Claims
1. An Internet-based method using computer software employing the
Extensible Business Reporting Language for enterprises (XBRL GL)
and/or Extensible Healthcare Reporting Language (XHRL), to provide
a secure testing service for patient's identification encrypted at
the data level, non-identifiable method for a patient to have a
genetic tests to identify variants or mutations of their genes or
combinations of genes that predispose the patient to develop or
have an identified disease, comprising: obtaining electronically
genomic information for a patient comprising at least one of, (a)
DNA information, (b) RNA information, (c) complementary DNA or RNA
information, (d) transfer RNA (tRNA) information (e) messenger RNA
(mRNA) information, and (f) Expressed Sequence Tags (EST) to
identify an abnormal gene; searching by one or more computers
electronic databases using the identified abnormal gene to obtain
genetic sequencing and basic research, patient predispositions, and
pharmacognetics that predict the response and reaction of patients
with identified genetic abnormalities related to the identified
abnormal gene and individual medications that may be prescribed
relating to the identified abnormal gene or a relationship with
said identified abnormal gene; performing an update search on at
least a periodic basis to learn about subsequent genomic research
developments and treatments for the identified abnormal gene,
specific genes with variants or mutated genes identified in the
genetic test; sending electronically via an Internet communication
link data comprising or derived from the searching step and the
update search to the patient or a third party; and with the sending
step performed using a privacy component that prevents transmission
to any third party unless predetermined permission clearance data
is in the system.
2. The method as defined in claim 1, further comprising providing
an application programming interface for accessing genetic testing
laboratories in the United States and internationally, using an
XBRL GL or XHRL medical taxonomy electronically linked to available
research on the developments in genetics and therapeutic lifestyle
changes or treatment of individuals with the variants in genetics
identified in the secure or encrypted test results, as it pertains
to the identified abnormal gene and update the existing data base
for the pre-specified gene.
3. The method as defined in claim 1, wherein the predetermined
permission data comprises identified third parties that may receive
the transmission based on a patient certification.
4. The method as defined in claim 1, further comprising
transmitting electronically an electronic update for a patient
medical record maintained in a central database developments.
Description
CROSS-REFERENCE TO RELATED PATENT APPLICATIONS
[0001] This application claims priority from Provisional
Application U.S. Application 61/006,785, filed Jan. 31, 2008,
incorporated herein by reference in its entirety. This application
incorporates by reference U.S. Provisional Patent Application No.
60/841,529 filed Sep. 1, 2006, U.S. Provisional Patent Application
60/957,094 filed Aug. 21, 2007, U.S. Provisional Patent Application
60/987,603 filed Nov. 13, 2007 and U.S. patent application Ser. No.
11/740,122 filed Apr. 25, 2007. These applications are incorporated
herein in their entireties.
BACKGROUND
[0002] Medical testing and the use of test results have always
raised patients' privacy issues concerning who can see the test
results and the use or misuse of the test results. Historically,
the results of a certain laboratory test raised issues of
discrimination toward the test taker, e.g., a positive HIV test.
With the introduction of genetic testing, the results of a test may
result in discrimination against several generations of the test
takers' family. This is compounded by the possibility of incomplete
or inaccurate medical science in misinterpreting the test results.
Genetic testing geometrically increases the risk of
misinterpretation or misuse of one generation's test results to
discriminate against the test takers' children and grandchildren
for employment or insurance rating purposes.
[0003] However, the promise of genetic testing and genetically
tailored prescriptions has extraordinary positive medical benefits.
This field is growing very rapidly and there are already over 1,000
genetic tests available from over 600 non-research clinics and
laboratories. A 2008 draft study of the HHS Advisory Committee on
Genetics, Health and Society indicated that today genetic tests
were useful to 2% of the population (including children and
elderly). That number is projected to grow to 60% of the population
when the tests already under development are available commercially
in the coming months. Over the next decade, the proportion of the
population that may benefit from genetic testing will continue to
grow, and their costs will decrease. Further, additional
multi-variable analysis will increase the diagnostic confidence of
the analyses.
[0004] In the coming years, the medical profession will be educated
about genetic tests, and the patients will become aware of them and
ask their physician about them. The HHS Advisory Committee
described the tests as "growing at an explosive rate" and said that
the medical profession's education efforts, " . . . cannot keep up
with the pace of development of genetic tests." The Advisory
Committee recognized that genetic tests were now being offered not
just through doctors, but also directly to consumers bypassing
doctors. Direct testing raises both test interpretation issues and
privacy issues, because of direct identification of the test
requestor, credit card payment record, etc.
[0005] Recognizing the issues relating to accurate interpretation
of genetic test results, there is unquestioned patient healthcare
value to the proper use of genetic tests by trained physicians.
Nevertheless, some patients are reluctant or refuse to take the
tests because they do not want to know the results. A probably much
larger number do not take the tests for fear that their genetic
predispositions will become known to their current or prospective
employer or life and health insurance companies through data mining
or other means. A person's genetic predisposition can result in
loss of employment or the inability to be hired. The life insurance
industry's medical database can contain this data and be widely
available. Patients also fear that they will have to produce these
test results in court in an adverse legal proceeding and will be
compelled to produce them in a lawsuit.
[0006] In 2007, the Center for Genetics and Public Policy conducted
a survey of consumer attitudes toward the use of genetic test's
data. Their principle conclusion was that:
[0007] "The majority of Americans enthusiastically support genetic
testing for research and health care, but a large majority (92%)
also expresses concern that results of a genetic test that tells a
patient whether he or she is at increased risk for a disease like
cancer could be used in ways that are harmful to the person."
[0008] In the Survey, 86% of the participants would trust their
physician with their genetic test results, but fewer than one out
of five trusted their employer with the information fearing
discrimination based on genetic testing. An identical 93% of the
respondents felt that the results should not be used by an employer
for future advancement or promotion and also that insurance
companies should not be able to use the results to deny future
coverage or charge higher rate insurance premiums. Over three out
of four surveyed felt that there should be a law that prevents
employers from using genetic test results about risk of future
disease and also to deny or limit insurance or charge higher
prices. (The Survey had a confidence level of plus or minus
2.7%.)
[0009] As a result of individuals legitimate privacy fears, many,
perhaps most, individuals and their doctors do not take genetic
tests, even those that may be most helpful in their own life style
decision making, healthcare regime, or even prophylactic treatment.
This fear of loss of privacy appears to be the prominent attitude
in the patient population. Once educated on these privacy issues,
people are still exceedingly reluctant to take genetic tests that
may be extremely helpful to them medically.
[0010] Searching for Updated Information for Mutated Genes
[0011] In addition, there is no way for a patient who takes a
genetic test to search about the genetic research that relates to
the abnormal genes that they possess. To follow developments in the
field of genetics or genetic medicines related to their particular
abnormal genes an individual must at present they must search all
of the professional medical journals, Google the genes of
particular interest to them or rely on their doctors to provide
them the information that they have found. Unfortunately, since
Google rankings are based on the number of times that a story,
subject, or hyper-text format page (HTML page) is referenced in the
internet, the reference to a particular gene may not be prominently
displayed or may rank so low that it is not effectively found by an
individual using Google or the gene is not linked or related to
other genes sufficiently often to be searchable by the patient or
the patient's doctor.
[0012] This situation is well illustrated by considering two
different sets of genes found in women. Assume that a woman has
abnormal BRAC1 and BRAC2 genes. Variants in the BRAC1 and BRAC2
genes appear to increase the probability of women getting certain
types of breast cancer from heredity. They are widely know, many if
not most women know this information, and they are searched on
Google many thousands or millions of times a day on a world wide
basis. As a result, they are highly ranked in the Google search.
Now consider a woman with the variants of the BLK and ITGAM genes
that contribute to the autoimmune disease Lupus. In the United
States, Lupus affects an estimated 1.5 million Americans; less than
0.5% of the population. More importantly, only a small proportion
of women with Lupus would be searching for BLK and ITGAM and
therefore the search results on Google and other search engines
would not highly display these search results.
[0013] Consider the number of search results referenced on the
upper right corner of a Google display and the number displayed in
the first ten or twenty pages of Google to realize that the search
results for the BLK and ITGAM related stories are effectively not
found and displayed by any search engine for a patient with variant
genes searching for new updates. While newspaper stories about a
development will provide enough "hits" to give the story temporary
prominence that is not targeted effective search, or a consistent
enduring ranking on Google.
[0014] Even more difficult is the search for information when more
than one variant gene set is involved in the apparent abnormality
that increases the probability of a disease. Again, using Lupus as
an example, consider that the BLK and ITGAM genes are part of an
estimated 20-30 genes linked to the disease. In the Jan. 22, 2008
Wall Street Journal, Dr. Timothy W Behrens and his colleagues
reported in the New England Journal of Medicine used what is
considered a significant powerful genetic-testing technology that
is providing insights into previously unrecognized genes linked to
Lupus. The more genes involved the relatively fewer the hits on
Google, therefore the lower the information's rankings and the more
difficult for a patient to search, discover or links subsequent
information relating their variant genes. Google can find, but not
array and display this information effectively and the individual
with the mutated genes are often not able to effectively obtain the
targeted or effective search of new information relating to ITGAM.
The following Google search results for BLK and ITGAM were used to
illustrate this point.
[0015] For example, at 8:00 PM EST on Jan. 28, 2008, Google
produced the following search results for "BLK": it has 34,400,000
search results, which are displayed 10 results at a time. For the
first 25 pages of results or 250 results, results for the gene BLK
were displayed only six times. All of the results were for the gene
coding itself and took over ten minutes to identify. None of these
results were obviously useful to an individual patient who had
mutations of the BLK gene. The search results were not prominent,
easily displayed, or usable from the search of the first 250
results. None of the six results told what the variant of the BLK
gene might mean to a patient who was told that they had the variant
gene. None of the search results provided any information relating
to Lupus. There was no effective search or medically useful
information for a patient with a mutation of the BLK gene seeking
to be informed of new developments on an ongoing periodic
basis.
[0016] By contrast, at 8:34 PM EST on Jan. 28, 2008, Google
produced the following search results for "ITGAM": it has 47,700
search results and the first ten displayed were about the protein
ITGAM in detail for someone interested the sequencing of the gene
itself. In the first ten results there were references to obesity,
but not Lupus. Again, there was no effective search or medically
useful information for a patient with a mutation of the BLK gene in
the display of results an interested person might read.
[0017] A subsequent Google search for "ITGAM+Lupus" provided 3,270
search results. In this much smaller search, all of the first ten
displayed search results appeared to be on point and it appeared
that many search results would be useful to a patient who made this
request. However, note that to receive the search result, the
patient-searcher had to know the disease specified before the
search. Since the purpose is to identify the disease caused by a
variant in a gene rather than requiring the searcher to know a
priori the disease that causes the genetic variant, the result
shows the need for a an invention that searches for the disease and
new developments in treatment knowing only the genetic title,
"ITGAM."
[0018] Even more interesting is the search for the gene BDFN.
Mutations of this gene have been preliminarily identified as a
cause [or the cause] of depression, a disease that is estimated to
affect 30-50 million Americans. The story, "When Fretting Is Your
DNA: Overcoming the Worry Gene" was in the Wall Street Journal on
Jan. 15, 2008; Page D1.
http://online.wsj.com/article/SB120035992325490045.html. Online it
was the most read and most e-mailed story for the Wall Street
Journal on that date. Hence it could be expected to be highly
ranked by Google. However, a Google search for DBFN at 9:35 AM EST
on Jan. 29, 2008 produced the following; there were 9,470 results.
Of the first 100 results only the 34.sup.th ranked result produced
useful genetic or medical information about DBFN and depression. In
the top 100 two others related DBFN to bulimia and adult weight
loss. During the top 100 search results, the Wall Street Journal
Story of January 15 was not ranked at all. Thus it is reasonable to
conclude that a person interested in DBFN gene developments won't
easily find them over time. At 9:49 AM EST, a more focused Google
search of "DBFN+Depression" produced only 45 results, and did not
include the Wall Street Journal. On the last page of results, the
following notice appeared;
[0019] "In order to show you the most relevant results, we have
omitted some entries very similar to the 32 already displayed. If
you like, you can repeat the search with the omitted results
included."
[0020] When the Google search was repeated with the omitted results
included, the same 45 results were repeated. Again, the Wall Street
Journal story of Jan. 15, 2008 "When Fretting Is In Your DNA:
Overcoming the Worry Gene." did not appear in the 45 search
results. This search for DBFN illustrates that there may be tens of
millions of people who can not find the relevant newly developed
information on Google as the research on DBFN and depression is
further discovered and published in the future. Neither the
patients suffering from depression nor their doctors are not likely
to have better search results using Google. Hence a patient or
doctor knowing a patient that has mutations of the DBFN gene does
not have an effective way to inform themselves of subsequent
developments relating to DBFN, nor possible treatments that may
develop subsequent to the genetic test. Following the research and
clinical developments in the genomic field is difficult without
help.
[0021] For example, the mutated KRAS (K-ras) gene is found in most
pancreatic and colon cancers. Data varies from study to study, but
between 40 percent and 60 percent of newly diagnosed colon cancer
patients have the well known non-mutated gene. The colon cancer
treatments are part of the ongoing attention given to the K-ras
gene and information showing it is a good determinant of how well a
patient will respond to the class of drugs called EGF receptor
inhibitors. Data from ImClone's Erbitux, presented at the American
Society of Clinical Oncology gastrointestinal cancer meeting over
the Jan. 26-27, 2008 weekend, suggest a benefit in patients with
the non-mutated K-ras gene. Amgen's Vectibix is already approved in
Europe as treatment for that class of patient and OSI's Tarceva
could have the same benefit. To find this new treatment
possibility, a patient would have to search the company web sites,
the ASCO website or specific drugs to learn this information,
because a search for K-ras on Google produces 492,000 results, and
it is not clear that the results even contains this new
information. The search results for 492,000 results does not
indicate the data is presented in a "findable" way. Yet all the
patient or his doctor may know is the mutated or non-mutated state
of the patient's KRAS and that the patient has colon cancer.
Because this new information isn't yet widely searched on the
internet it doesn't rank high in the Google search results for KRAS
at this time. Yet these are precisely the type of new developments
that are vitally important to a cancer patient and their
doctor.
[0022] Prior Art: In response to this wide-spread patient
reluctance to genetic testing where the patient and their results
can be identified, some laboratories have begun to offer anonymous
testing and even some third-parties may have started offering this
type of trusted third-party service. These are generally related to
the laboratory offering the test and not and independent service
that will work with all laboratories. None offer web based updates
of research or clinical information focused on the mutated or
variant genes identified in the requesting individual (patient's)
genetic test.
[0023] There is prior art involving a trusted third-party payer,
particularly on the internet. The service PayPal is the best known
of these services, but they are not related to personal healthcare
records, genetic testing, and do not provide an ongoing service,
but are one time transactional services.
[0024] A United States Patent and Trademark Office search of
patents and published applications using "genetic testing and
privacy" for All Fields produced 57 responses, but none were close
to the Invention. U.S. Pat. No. 6,944,767 Method and Apparatus for
Ensuring the Privacy and Security of Personal Medical Information
addressed the privacy issues, but with an unrelated apparatus or
device.
[0025] Outside the United States Patent and Trademark Office, it
appears that on Apr. 27, 2005 NTT announced the existence of a new
product SecureName, which is an XML system to provide privacy
protection in medical records. On Apr. 27, 2007, Microsoft
announced an LLP partnership with NTT to use their SecureName
technology. It appears that it is a part of the Microsoft Health
Vault product, which has been in the public domain for less than
one year prior to this filing. The NTT SecureName technology is XML
and may be partial prior art for a portion of this Invention.
[0026] There is no prior art that permits a person to designate a
particular gene, gene set, or linked set of genes to use in
establishing an ongoing or recurring search of pathology research
relating to the improvement in knowledge about a gene, its
relationship to other genes or their probability of influencing or
determining a patient's probability of contracting a certain
disease or medical condition. There is no ability to search and
identify the variants in gene, gene sequence, or linked gene
behavior that provides the patient with any probabilities of
disease, suggestion of changes in lifestyle or prophylactic
treatment to either lessen the severity of a disease, to arrest its
development, or to cause remission or treatment to alleviate its
symptoms.
[0027] The Company 23 and Me was publicly launched Nov. 19, 2007.
It provides a web based testing service for people to have their
own genome sequence examined for $999 by sending in a sample,
personal information, account information, and alike. The Company's
Privacy Policy indicates that it will not sell the individual's
personal, account, or genomic data without the individual's
consent. The requesting individual's identification information is
known to the Company prior to their data being destroyed. The
Company says that it will sell the genomic information
de-identified from the personal information, but it is not clear
what restrictions exist on this. It links to other websites, but
does not provide a service to follow up and inform the test taker
of the new research and clinical information about their mutated
genes. It does not provide privacy and security for patients
wishing to use any laboratory. Last, it has not been in the public
domain for a year or more and therefore is not prior art. See
www.23andMe.com
[0028] Quest Diagnostics is a testing company for Physicians that
performs genetic testing and offers interpretation of the test
results and the counseling for the test taker. It does not provide
updates on the genetic mutations of the test taker, and the test
taker's identify is known to the laboratory. They would be a
laboratory that the test taker or used through a physician on a
confidential basis. See www.questdiagnostics.com
[0029] deCODE Genetics is genetic testing service company based in
Iceland. It was launched Nov. 16, 2007. It provides an online
service for individuals to use PayPal to pay and will provide
genetic profiles of the individual. It provides a great deal of
counseling and contest to help the test taker understand the
results of their genetic test, which is performed by a related
laboratory. They will also inform a test taker of updates in the
research about their genes. The Company's main thrust is to help
people understand their genetic profile compared to other
individuals and groups and not as a medical diagnostic tool. The
individual who requests the test is known to deCODE Genetics. See
www.decodeme.com.
[0030] A fourth company, Navigenics, specializes in personalized
consumer health and wellness services, with the overall goal of
improving health outcomes in individuals across the population.
Navigenics educates and empowers customers with knowledge of their
genetic predispositions, and then motivates them to act on the
information to prevent the onset of disease, achieve earlier
diagnosis, appropriately manage disease, or otherwise lessen its
impact. It was publicly launched on Nov. 6, 2007. It provides
genetic testing, but not on an anonymous basis, the requester is
known to the Company, and there is no indication that the Company
will not sell the requesting party's genetic information or use it
for other commercial purposes. In its $2,500 testing price, it
specifically will provide of an update of new genetic discoveries
for a year, but does not provide a continuing service, nor any
search or updating based on the tested individual's mutated genes.
See www.navigenics.com.
[0031] In sum, there is some prior art in many facets of the
invention, but not for the invention itself. Most of the companies
above, Navigenics, 23 and Me, deCODE Genetics, and Quest
Diagnostics are testing laboratories that someone using the
invention could access anonymously and be provided updates from
their public reports as well as studies from Science, Nature, the
New England Journal of Medicine, other medical journals in the
United States and internationally, which can use XBRL's translation
features to be linked in English to the gene or combination of
mutated genes that are being tracked for the tested individual. All
of these companies are potential testing facilities for the
patient's that would use an anonymous genetic testing service.
[0032] All of the testing facilities mentioned, Navigenics, 23 and
Me, deCODE Genetics, and Quest Diagnostics have begin operation
within one year prior to the filing of this patent application, and
most have been in the public domain only since the 4.sup.th quarter
of 2007.
BRIEF DESCRIPTION OF THE DRAWINGS
[0033] FIG. 1 is an overview of the secure genetic testing
invention.
[0034] FIG. 2 illustrates the continuous updating of newly
developed genomic research or medical related advances for
prescribing pharmaceuticals or advances in gene therapy.
[0035] FIG. 3 is an overview of the Patients Privacy Trust
DETAILED DESCRIPTION
[0036] The invention is a web based method and system using
computer software employing the Extensible Business Reporting
Language for enterprises (XBRL GL) and/or Extensible Healthcare
Reporting Language (XHRL), to provide a secure testing service for
patient's identification and payment data encrypted at the data
level, non-identifiable method for a patient to have a genetic
tests to identify variants or mutations of their genes or
combinations of genes that predispose the patient to develop or
have an identified disease. The genomic information comprises at
least one of, (a) DNA information, (b) RNA information, (c)
complementary DNA or RNA information, (d) transfer RNA (tRNA)
information (e) messenger RNA (mRNA) information, and (f) Expressed
Sequence Tags (EST). The computer software uses the identified
abnormal genes to search for genetic sequencing and basic research
relating to the identified abnormal genes or future combinations of
genes not known at the time of the original test. This provides a
service for the patient to learn about subsequent genomic research
developments and treatments for the specific genes with variants or
mutated genes identified in the genetic test. This includes
searching for an identifying subsequently identified genetic
sequences or relationships between genes and future pharmacognetics
that predict the response and reaction of patients with identified
genetic abnormalities to individual medications that may be
prescribed, e.g. personalized or patient centric prescriptions
based on their genetic composition. The software will also search
for developments relating to predisposition to certain diseases and
generational transmission of the predispositions.
[0037] The software will provide an application programming
interface to the genetic testing laboratories in the United States
and internationally, such as Navigenics, 23 and Me, Quest
Diagnostics, and deCODE Genetics, and others will be added. An XBRL
GL or XHRL medical taxonomy will be electronically linked to all
available research on the developments in genetics and therapeutic
lifestyle changes or treatment of individuals with the variants in
genetics identified in the secure or encrypted test results. It
will search the internet for the relevant results relating to the
specified genes and update the existing data base for the
pre-specified gene. The software will then process, and transmit
the focused search to the patient in a secure or non-secure manner
to update the patient on medical developments that occur subsequent
to the patient's first or initial genetic test. The software can
also related diseases linked to certain mutated genes and identify
future basic research and therapeutic of pharmacognetics
developments for that disease relating to genes not found to be
mutated in the original genetic test. This invention is illustrated
in FIG. 1. The continuous updating of newly developed genomic
research or medical related advances for prescribing
pharmaceuticals or advances in gene therapy is illustrated in FIG.
2.
[0038] This invention incorporates by reference three previously
filed patent applications. U.S. Patent Application No. 60/957,094
Methods, systems, and computer software using XBRL technology to
electronically link independently developed topical sets of
semantic medical vocabulary standards into a comprehensive XBRL
taxonomy that enables a patient to have a single integrated
electronic medical record with agreed upon definitions that can be
interoperable on any computer using any software, which was filed
Aug. 21, 2007. The second patent incorporated by reference is U.S.
Patent Application No. 60/841,529 Methods systems and computer
software utilizing XBRL to capture patient's health care data,
including the patient's genotypic data or genotype to improve the
matching of treatments drugs and devices to a patient's unique
genetic make up, filed Sep. 1, 2006. The third patent incorporated
by reference is U.S. Patent Application No. 60/987,603 Methods,
systems, and computer software using individual and aggregate
healthcare data, and morphing technology to morph an individual's
digital photograph and life style data to project their probable
appearance, aging, and health status over time given alternative
life style choices, filed Nov. 13, 2007.
[0039] Embodiments: In one embodiment, the patient (or the
patient's physician) indicates an interest in obtaining a genetic
test of all or part of a patient's genetic make-up or sequencing.
The anonymous Genetic Testing Service (the "GTS") obtains and
accepts the patient's DNA sample, instructions, and payment, and
de-identifies the patient and all related material that could
identify the patient. It does this by encrypting all individual
data field in the patient's name, date of birth, address, and alike
using a large encryption program, e.g., 258,000 factorial on each
data item in the patient's name, address, date of birth and alike
and storing the encrypted data off shore.
[0040] After de-identification, the GTS requests a genetic testing
laboratory to conduct a specified genetic test on the patient's DNA
de-identified sample. The GTS also pays the genetic testing
laboratory from its bank account. After the genetic test is
complete and the results are tabulated, the laboratory sends the
genetic testing results to the GTS. The GTS then uses its internal
encrypted key to identify the patient, and the GTS can then
transmit the genetic test results to the patient or the patient and
the patient's physician.
[0041] The GTS will establish application programming interfaces to
the leading genetic testing facilities to request, process, and pay
for the anonymous genetic testing and in turn to receive the
genetic test results anonymously from the testing laboratory, e.g.
23 and Me or Navigenics, and deCODE Genetics, plus others on a
global basis. Use of the GTS assures the patient or patient's
physician that their identity can never be known by the testing
laboratory, because they never received anything other than a GTS
code.
[0042] After testing, the GTS computer software can identify the
patient's genes that are mutated or the patient (or the patient's
physician) can request the GTS to identify and report on all
subsequent developments relating only to the genes identified as
being variant in the genetic test or those specific genes
designated by the patient or the patient's physician as being of
interest to them. The GTS's computer software then does a periodic
internet search of developments relating to the specified genes and
uses a multi-factor search on the results, including frequency of
mention, but also on closeness to the issue of healthcare
implications for the patient. The search results are arrayed by
degree of closeness to the patient's specified interest, frequency
of mention in the rankings, and other factors to make the results
as narrow or useful to the patient or the patient's physician for
recommendations relating to changes in the patient's lifestyle or
prescribed medicines for the patient given the original genetic
variations, and the subsequent research knowledge about the gene,
its links to other genes, combination of genes and internet search
results relating to the changes in life style or medicines for the
patient. These stratified or narrowed internet search results are
arrayed, stored, and transmitted or made available to the patient
in a secure manner so that the identify of the patient is not
identifiable or even that the patient or patient's physician has
requested or paid for the continued monitoring or is receiving the
continued updates monitoring. In addition, all identification and
payments records relating to the transaction (s) with the patient
or the patient's physician are encrypted by individual data field
and stored in a selected location or jurisdiction so that they may
not be subpoenaed by a United States court or the court of the
patient's home country.
[0043] In a second embodiment, The SGT will operate as follows. SGT
would be a combination of physical processing and internet based
services, all structured so that the information, physical sample,
and test results are not owned by SGT, but only managed by them as
a trustee of the patient owner. All of following actions are done
by SGT acting as a trustee or agent for the patient owner of the
data. The SGT would be a trust located in an appropriate
jurisdiction and it would have a contract with a management company
for management services to provide its member benefits.
[0044] To collect the samples the service would use FedEx or a
similar service. The request for a test could come over the
internet, by telephone, or by use of a pre-distributed set of
sample collectors in doctor's offices or drug stores and FedEx
prepaid addressed envelopes. If the request is over the internet,
the requester can be sent the sample collection kit, a return
pre-addressed FedEx envelop, and credit card authorization. These
are all sent to a central processing facility, perhaps at the
Memphis Airport to take advantage of the FedEx processing
facility.
[0045] SGT would input and record the requesting party's data,
encrypt it, and send it to an SGT server farm in a secure
non-United States jurisdiction, currently assumed to be Singapore.
The encryption would not only be of the requestor's name, but also
all potentially identifying data such as address, credit card
number, etc. These data would be encrypted using commercially
available techniques, but on the meta-data on each letter in all of
the potentially identifying data. Using available XBRL GL
technology, each letter (data field) with a 258,000 factorial so
that the combined factorials are so large they are beyond
commercial code breaking feasibility.
[0046] The SGT would transmit the request for the test to the
designated testing laboratory, forward the patient's sample, which
has been de-identified, and pay the laboratory using SGT funds to
cover the cost of the testing. After testing, the results would be
transmitted to SGT, which would re-identify the requester of the
test, and transmit the test results to the original requestor. This
process is illustrated in the accompanying Exhibit I.
[0047] The SGT would retain no records of the requester, the
requestor's payment method or the requestor's physician in the
United States that could be subsequently subpoenaed in a lawsuit.
Data on the requester, etc., outside the United States would only
be retained for a limited time, and then it would be destroyed as a
part of a regular data retention management program. Prior to
destruction of the requestor's data, the SGT would maintain an
electronic audit trail that indicates any request for, viewing, or
modification of the requestor's demographic or payment information
and subsequent test results information.
[0048] The SGT would provide secure and non-secure basis
information about genetic research on specific genes and the
interpretation of the meaning of mutations or abnormalities of
genes or combination of linked genes. A non-test taker could
subscribe on a non-secure or secure basis. A previous genetic test
taker could subscribe on an anonymous basis that could not be
related to their having taken a test and expressed an interest in
following research and interpretation of findings concerning a
particular gene or combination of genes.
[0049] This subscription service is expected to be popular because
most people will only take their genetic test once or twice. To the
extent that they identify one or a number of linked genes that
contain a variant indicating a genetic predisposition, they can
follow the medical research and best interpretative practices on
that gene or combinations involving that gene without searching the
Internet for all research. The SGT would search and rank the
research, and provide it to the subscriber in a data feed RSS or
e-mail or through a coded web site that only has information
relating to the gene that the subscriber has designated to be of
interest.
[0050] In a third embodiment, the GTS uses XML and its encryption
capabilities to provide a less robust encryption of the patient
data. Otherwise, the embodiments are identical with embodiment one
and embodiment two described above in this application.
[0051] In a fourth embodiment, a patient has not been genetically
tested, but wants to follow developments relating to genetic
sequencing or medical research about a particular gene. No patient
sample is collected or tested. However, the identification of the
patient or patient's doctor requesting information of future
developments on sequencing and possible lifestyle or therapeutic
treatments is still de-identified and the information encrypted
using XML or XBLR GL coding and formatting technology to protect
the requesting party, their payment mechanism, etc. These records
would also be established and stored in a jurisdiction where the
party requesting the information could not be compelled to provide
them by a court in the requesting party's home legal
jurisdiction.
[0052] In a fifth embodiment, the patient or patient's physician
does not do a genetic test for mutated genes, but rather specifies
that they would like the literature on certain genes or
combinations of genes tracked on an ongoing basis. This may be done
as an anonominous request or done on an identified name basis. The
software would accept this request, search, manage and transmit the
future data on an ongoing basis. This is similar to the other
embodiments above.
[0053] In a sixth embodiment, the computer software would use the
set of identified mutated genes to search for future basic research
and pharmacognetics related to them for the identified diseases the
mutated genes predispose the patient to have. It would use that
list of diseases to diseases to track developments relating to the
patient's non-abnormal genes and subsequently relate them. In this
embodiment, the computer software would provide a feedback loop of
research and therapeutic information to the patient based on
subsequent developments in the genetics or clinical treatments
based on knowledge developed after the initial test. These data
would be identified, sorted, stored, transmitted and displayed
separately classified from the subsequently discovered information
relating the patient's abnormal genes in the original test.
Patients Privacy Trust Concept Paper
[0054] This paper develops the concept of the Patients Privacy
Foundation (the "Foundation") and e-certus (the "sponsors")
developing a service to provide assured anonymity to individuals
taking sensitive laboratory tests, particularly genetic tests, and
the ability to receive focused medical research literature
concerning any genes they identify to monitor,. It outlines the
privacy issues, and then discusses the desirability of establishing
an anonymity service, and its operational features. It concludes
with a discussion of the sponsors' objectives, outlines a financial
arrangement, and lists next steps. This discussion draft is
designed to stimulate additional ideas and proposals for final
concept paper.
[0055] Privacy Issues
[0056] Medical testing and the use of test results have always
raised patients' privacy issues concerning who can see the test
results and the use or misuse of the test results. Historically,
the results of a certain laboratory test raised issues of
discrimination toward the test taker, e.g., a positive HIV test.
With the introduction of genetic testing, the results of a test may
result in discrimination against several generations of the test
takers' family. This is compounded by the possibility of incomplete
or inaccurate medical science in misinterpreting the test results.
Genetic testing geometrically increases the risk of
misinterpretation or misuse of one generation's test results to
discriminate against the test takers' children and grandchildren
for employment or insurance rating purposes.
[0057] However, the promise of genetic testing and genetically
tailored prescriptions has extraordinary positive medical benefits.
This field is growing very rapidly and there are already over 1,000
genetic tests available from over 600 non-research clinics and
laboratories. A 2008 draft study of the HHS Advisory Committee on
Genetics, Health and Society indicated that today genetic tests
were useful to 2% of the population (including children and
elderly). That number is projected to grow to 60% of the population
when the tests already under development are available commercially
in the coming months. Over the next decade, the proportion of the
population that may benefit from genetic testing will continue to
grow, and their costs will decrease. Further, additional
multi-variable analysis will increase the diagnostic confidence of
the analyses will
[0058] In the coming years, the medical profession will be educated
about genetic tests, and the patients will become aware of them and
ask their physician about them. The HHS Advisory Committee
described the tests as "growing at an explosive rate" and said that
the medical profession's education efforts, " . . . cannot keep up
with the pace of development of genetic tests." The Advisory
Committee recognized that genetic tests were now being offered not
just through doctors, but also directly to consumers bypassing
doctors. Direct testing raises both test interpretation issues and
privacy issues, because of direct identification of the test
requestor, credit card payment record, etc.
[0059] Recognizing the issues relating to accurate interpretation
of genetic test results, there is unquestioned patient healthcare
value to the proper use of genetic tests by trained physicians.
Nevertheless, some patients are reluctant or refuse to take the
tests because they do not want to know the results. A probably much
larger number do not take the tests for fear that their genetic
predispositions will become known to their current or prospective
employer or life and health insurance companies through data mining
or other means. A person's genetic predisposition can result in
loss of employment or the inability to be hired. The life insurance
industry's medical database can contain this data and be widely
available. Patients also fear that they will have to produce these
test results in court in an adverse legal proceeding and will be
compelled to produce them in a lawsuit.
[0060] In 2007, the Center for Genetics and Public Policy conducted
a survey of consumer attitudes toward the use of genetic test's
data. Their principle conclusion was that:
[0061] "The majority of Americans enthusiastically support genetic
testing for research and health care, but a large majority (92%)
also express concern that results of a genetic test that tells a
patient whether he or she is at increased risk for a disease like
cancer could be used in ways that are harmful to the person."
[0062] In the Survey, 86% of the participants would trust their
physician with their genetic test results, but fewer than one out
of five trusted their employer with the information fearing
discrimination based on genetic testing. An identical 93% of the
respondents felt that the results should not be used by an employer
for future advancement or promotion and also that insurance
companies should not be able to use the results to deny future
coverage or charge higher rate insurance premiums. Over three out
of four surveyed felt that there should be a law that prevents
employers from using genetic test results about risk of future
disease and also to deny or limit insurance or charge higher
prices. (The Survey had a confidence level of 2.7% plus or
minus.)
[0063] As a result of individuals legitimate privacy fears, many,
perhaps most, individuals and their doctors do not take genetic
tests, even those that may be most helpful in their own life style
decision making, healthcare regime, or even prophylactic treatment.
This fear of loss of privacy appears to be the prominent attitude
in the patient population. Once educated on these privacy issues,
people are still exceedingly reluctant to take genetic tests that
may be extremely helpful to them medically.
[0064] In response to this wide-spread patient reluctance to
genetic testing where the patient and their results can be
identified, some laboratories have begun to offer anonymous testing
and even some third-parties may have started offering this type of
trusted third-party service. (The extent of anonymous testing today
will be researched in the coming weeks.)
[0065] Establishing a Patients Privacy Trust
[0066] Given the magnitude of the problem and the projected growth
of genetic tests, laboratories, and the education of the healthcare
professionals on their value, there appears to be an opportunity to
establish an anonymity service to meet the privacy needs of the
patients and physicians. This service will provide assurance to
them that their test results will be owned by them and only known
to them. If they choose to involve their physician, the physician
and patient can be assured that the doctor-patient confidentiality
will be maintained.
[0067] The anonymity service, with the initial working title,
Patients Privacy Trust ("PPT") will be a trusted-third party that
could provide assurance of anonymity through computer encryption of
patient identities and the locating of the services records in a
jurisdiction where they could not be subpoenaed in a United States
civil lawsuit, e.g., Singapore. This is important to prevent the
disclosure of not only the patient's test results, but also the
fact that the patient even used the anonymity service. The
anonymity service would legally only be the trustee for the
patient's information, laboratory sample, and test results.
[0068] The anonymity service would utilize the Extensible Business
Reporting Language (XBRL) with meta-data on all data fields to
encrypt a patient's identifiers, payment method, code for sample,
and alike. This will permit the commercial use of a 258,000
factorial on each letter or number (data field) in the patient's
identifying data. It will also provide the capability for an
electronic audit of any viewing of the data for security purposes.
At present, e-certus has a patent pending on the electronic audit
trail in healthcare. In late January, it will file a new patent on
some additional features that will be disclosed to all individuals
or organizations signing its NDA. After filing, these features in
the business method patent will be public.
[0069] Given its planned policies, the PPT should be able to obtain
an errors and omissions insurance policy that could provide very
high limits, which could assure potential patients of the
seriousness with which their anonymity would be protected, e.g.,
"$10 million per occurrence, and $100 million coverage." The
anonymity service's business model should enable it to obtain
substantial coverage limits for reasonable premiums. The insurance
could cover the fact that the service will neither data mine or
sell the patient's data in anyway, and that violation of that
policy can result in patient claims and payouts under the insurance
policy.
[0070] These features combined with the endorsement or
certification of the Patient Privacy Foundation should enable an
anonymity service to dominate the secure genetic testing market In
fact, the PPT can also offer a service to its test takers what will
provide them with all of the new medical research on their specific
genes that test with an abnormality.
[0071] This will ensure that they can securely receive all of the
information focused only on the genes that they are concerned.
[0072] The PPT would not perform any testing or interpretation of
genetic testing, nor make any recommendations concerning testing
laboratories or physicians or services for the interpretation of
the test results. It would simply be the trustee of the test
requestor's data, and provide a subscription service of medical
research findings relating to the genes the requester selected to
be informed about in the future, e.g., BRAC 1 and BRAC2. In this
role, it is an information service, and does not provide any
analysis or interpretation of the data.
[0073] Products and Services
[0074] The PPT will do two things. First, it would provide
guaranteed anonymity to genetic test takers and their physicians.
Second, it would search and provide a subscription data service to
the genetic test takers or their physicians concerning all future
developments in medical research or interpretation of findings
relating to the specific genes the test takers or their physicians
specify.
[0075] Operational Features
[0076] The anonymity service, with the working title, Secure
Genetic Testing ("PPT") will operate as follows. PPT would be a
combination of physical processing and internet based services, all
structured so that the information, physical sample, and test
results are not owned by PPT, but only managed by them as a trustee
of the patient owner. All of following actions are done by PPT
acting as a trustee or agent for the patient owner of the data. The
PPT would be a trust located in an appropriate jurisdiction and it
would have a contract with e-certus for management services to
provide its member benefits.
[0077] To collect the samples the service would use FedEx or a
similar service. The request for a test could come over the
internet, by telephone, or by use of a pre-distributed set of
sample collectors in doctor's offices or drug stores and FedEx
prepaid addressed envelopes. If the request is over the internet,
the requestor can be sent the sample collection kit, a return
pre-addressed FedEx envelop, and credit card authorization. These
are all sent to a central processing facility, perhaps at the
Memphis Airport to take advantage of the FedEx processing
facility.
[0078] PPT would input and record the requesting party's data,
encrypt it, and send it to an PPT server farm in a secure
non-United States jurisdiction, currently assumed to be Singapore.
The encryption would not only be of the requestor's name, but also
all potentially identifying data such as address, credit card
number, etc. These data would be encrypted using commercially
available techniques, but on the meta-data on each letter in all of
the potentially identifying data. Present plans are to encrypt each
letter (data field) with a 258,000 factorial so that the combined
factorials are so large they are beyond commercial code breaking
feasibility. This level of encryption and the accompanying
procedures should ensure that PPT purchase substantial amounts of
insurance to advertise to potential users.
[0079] The PPT would transmit the request for the test to the
designated testing laboratory, forward the patient's sample, which
has been de-identified, and pay the laboratory using PPT funds to
cover the cost of the testing. After testing, the results would be
transmitted to PPT, which would re-identify the requestor of the
test, and transmit the test results to the original requester. This
process is illustrated in the accompanying Exhibit I.
[0080] The PPT would retain no records of the requester, the
requestor's payment method or the requestor's physician in the
United States that could be subsequently subpoenaed in a lawsuit.
Data on the requester, etc., outside the United States would only
be retained for a limited time, and then it would be destroyed as a
part of a regular data retention management program. Prior to
destruction of the requestor's data, the PPT would maintain an
electronic audit trail that indicates any request for, viewing, or
modification of the requestor's demographic or payment information
and subsequent test results information.
[0081] Subscription Genetic Data Service
[0082] The PPT would provide secure and non-secure basis
information about genetic research on specific genes and the
interpretation of the meaning of mutations or abnormalities of
genes or combination of linked genes. A non-test taker could
subscribe on a non-secure or secure basis. A previous genetic test
taker could subscribe on an anonymous basis that could not be
related to their having taken a test and expressed an interest in
following research and interpretation of findings concerning a
particular gene or combination of genes.
[0083] This subscription service is expected to be popular because
most people will only take their genetic test once or two times at
the most. To the extent that they identify one or a number of
linked genes that contain a variant indicating a genetic
predisposition, they can follow the medical research and best
interpretative practices on that gene or combinations involving
that gene without searching the Internet for all research. The PPT
would search and rank the research, and provide it to the
subscriber in a data feed RSS or e-mail or through a coded web site
that only has information relating to the gene that the subscriber
has designated to be of interest.
[0084] The value of a subscription service to track genomic
research and empirical medical treatments relating to the gene is
confirmed by two articles in the Jan. 22, 2008 Wall Street Journal.
They demonstrate both the pace of development in genetic testing
and need for a carrier of a mutated gene to know the developments
in medicine relating to that specific gene.
[0085] First, the Wall Street Journal reported discovery of two new
genes, BLK and ITGAM that contribute to the autoimmune disease
Lupus. Lupus affects an estimated 1.5 million Americans and is
widely considered to be under diagnosed and reported. The two genes
are part of an estimated 20-30 genes linked to the disease. Dr.
Timothy W Behrens and his colleagues reporting in the New England
Journal of Medicine used what is considered a significant powerful
genetic-testing technology that is providing insights into
previously unrecognized genes linked to Lupus. A subscriber to the
service would receive all of the future research related to the
research on the BLK and ITGAM genes and their links.
[0086] Second, the same Wall Street Journal reported three studies
about the identification of the gene mutation in KIF6, estimated to
be present in 60% of the population and that causes a 55% increase
in the risk of stroke or heart attack. "The impact of the variant
was independent of such conventional cardiovascular risk factors as
smoking status, cholesterol levels and diabetes." Importantly, the
studies confirmed that carriers of the variant taking a statin to
lower cholesterol had improvements in their risk of heart attacks
and strokes. For example, individuals with the KIF6 variant had a
37% reduction in their risk of heart attack by taking the statin
Pravachol independent of other variables, e.g. smoking or
non-smoking. These results are reported in four large studies
involving over 30,000 patients, and the results are available at
http://content.online-jacc.org/in_press.dtl, which is the online
edition of the American Journal of Cardiology. Several laboratories
are beginning to market a $200 genetic test for KIF6.
[0087] No only will carriers of mutated genes wish to follow the
development of genetic research about them, but their physicians
will have a keen interest in following the developments. The Wall
Street Journal reported that one cardiologist involved in the KIF6
study said, "the results `take us one step closer to personalized
medicine` in which doctors use genetic data to tailor therapy for
patients." It is reasonable to assume that a patient's physician
will have an interest in following a tested patient with variants
not only to improve treatment, but to minimize their risk of future
malpractice suits for failure to use the latest available treatment
in personalized medicine.
[0088] In sum, the proliferation of ever less expensive genetic
tests marketed to physicians and directly to the public plus the
continuing developments of genetic research suggests that the
demand of the subscription service is growing. Again, it can be
offered on a secure basis to previous genetic test takers or to
others interested in following a research about a particular gene.
The subscription service can become a useful tracker of
developments for personalized genetic medicine on a gene by gene
basis.
[0089] Privacy Foundation Leadership
[0090] At this time, most of the operational details remain to be
developed, assuming there is agreement on the concept, approach,
and market opportunity. The Foundation would be the public face of
the PPT and handle all public relations and press concerning its
operation, supported by e-certus as necessary. In effect, the PPT
would be the Foundation's private label testing service to provide
anonymity services to patients.
[0091] The Foundation will take the lead in the education of the
public to teach them that there are both benefits from genetic
testing and privacy issues relating to genetic testing, that PPT is
available, and how it can protect their medical privacy. PPT can
help the Privacy Foundation prepare material; arrange press and
television appearances, etc. However, the Foundation will have full
editorial control over the material except for technical operating
matters, which will be joint control.
[0092] Sponsors Objectives
[0093] The Foundation wishes to inter into an exclusive
relationship with e-certus to launch and build the PPT. Similarly,
e-certus wishes to enter into an exclusive relationship with the
Foundation to launch and build the PPT. Each believes that the
other sponsor can help them increase patient privacy, particularly
around the question of genetic testing, and helping patients find
out targeted information about medical developments relating the
genetic markers that the patient designates. The Foundation will
not work on a similar product or service with another Company. And,
e-certus will not work with nor license any of its intellectual
property with another Company or organization on a similar product
or service.
[0094] The Foundation needs to promote awareness and education
about medical health records privacy. Educating the public is a
major challenge. In addition, if the Foundation can sponsor a
service that meets its policy objectives and standards it will
increase awareness in the general community. If it can ensure that
a patient's genetic testing data is not misused, it may promote the
responsible use of genetic testing and limit the potential for
patient's private test data to be misused. If it can help patients
by narrowing their search for information to only the future
research and best practices healthcare interpretation of new
information about a gene or combination of genes, it can minimize
the probability that this will lead to employment or insurance
misuse of genetic testing results. These objectives may be achieved
by the Foundation receiving cash flow from the PPT operations that
can support the Foundation in a number of its related patient
privacy activities, e.g., legislative changes.
[0095] e-certus' objectives are to demonstrate in healthcare
several of the features of its XBRL coding, formatting, and linking
technology, which directly support the Foundation's patient privacy
objectives. This very high profile effort with the Foundation is
congruent with e-certus' short-term revenue and profit objectives,
but also increases the visibility and acceptance of its XBRL based
technology in healthcare, and particularly the Health Care
Information Technology Standards Panel ("HITSP") effort, where it
seeks to be designated the national data standard for healthcare
under Executive Order 13410. The Company believes that only its
technology will achieve all of the Foundation's privacy objectives,
which it supports.
[0096] Both sponsors agree that the Foundation will be the public
face or identity of the PPT and that e-certus will provide the
legal, technical, managerial services to PPT. The PPT will
reimburse the Foundation for normal and customary expenses incurred
on behalf of the PPT. Each of the sponsors will enter into an
agreement licensing their respective names, intellectual properties
(patents and copyrights), business methods, etc. to the PPT, which
at present is assumed to be an LLC, probably domiciled outside the
United States. The intent is that this will be a long-term and
hopefully permanent business relationship. The location of the
testing service and the ongoing subscription data feed are being
evaluated at this time.
[0097] e-certus will assume the responsibility for capitalizing the
PPT, preparing a business plan that includes examination of legal
issues and technical operation. Foundation will be involved in this
process and their involvement sought. In addition, PPT and e-certus
will have separate accounting system for all related expenditures
and Foundation will have complete access to this information
subject to the normal and customary business practices.
[0098] Further, Foundation will select a nationally recognized
certified public accounting firm for PPT and to audit the e-certus
expenditures relating to PPT. The expense of the certified public
accounting firm will be paid by PPT. The public accounting firm
will be specifically charged with ensuring that e-certus does not
overcharge the PPT with inappropriate expenses.
* * * * *
References